Chronic Ankle Instability (mainly characterized by recurrent lateral ankle sprains, giving way sensation, feeling of instability during walking or sports, pain, swelling, and limited activity)
Conditions
Interventions
Control group:Established imported absorbable product
Experimental group:Novel absorbable tendon/ligament fixation screw.
Sponsors
Beijing Jishuitan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years and 6 months) and failed conservative treatment; 3. No previous ipsilateral ankle-hindfoot surgery; 4. Able to understand the study purpose, voluntarily participate and sign informed consent, independently complete valid questionnaires, and willing to comply with the required clinical follow-up.
Exclusion criteria
Exclusion criteria: 1. Ankle osteoarthritis (Takakura stage 3a or higher); 2. Previous ipsilateral ankle ligament surgery; 3. Patients with severe hepatic or renal insufficiency, serious cardiovascular, cerebrovascular or other severe diseases; 4. Systemic connective tissue disease or metabolic bone disease; 5. Pregnant or breastfeeding women; 6. Other severe systemic diseases making the patient unable to tolerate surgery; 7. Currently participating in another drug or medical device clinical trial and not yet reached its primary endpoint; 8. Patients considered unsuitable for participation in this clinical trial by the investigator for any other reason;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Karlsson Ankle Score postoperatively;Incidence of intraoperative and short-term (=6 months) adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood biochemistry (liver function: ALT, AST; renal function: Cr, BUN; electrolytes: Ca, P);Patient satisfaction score;Complete blood count;Ligament healing assessed by ankle MRI;Postoperative Tegner Activity Score;Karlsson Ankle Score at 6 weeks and 3 months postoperatively;Postoperative AOFAS Ankle-Hindfoot Score;Postoperative VAS pain score; | — |
Countries
China
Contacts
Public ContactXiaofeng Gong
Beijing Jishuitan Hospital, Capital Medical University
Outcome results
None listed